Home › Device types › PTM
Syringe, Balloon Inflation, Exempt
FDA product code PTM · Class 2 · Cardiovascular
173
Registered devices
55
Adverse events
7
Recalls
0
510(k) clearances
Devices with this code
basixCOMPAK™ — Merit Medical Systems, Inc.basixTau™ — Merit Medical Systems, Inc.basixTOUCH™ — Merit Medical Systems, Inc.basixCOMPAK™ — Merit Medical Systems, Inc.basixALPHA™ — Merit Medical Systems, Inc.Sunmed Inflation Device — Sunny Medical Device (Shenzhen) Co., Ltd.GM-30 Accessory Kit — Nipro Vascular Innovations Americas, Inc.Arcadia™ — Merit Medical Systems, Inc.Angioway — Lepu Medical Technology (Beijing) Co.,Ltd.basixCOMPAK™ — Merit Medical Systems, Inc.basixTOUCH™ — Merit Medical Systems, Inc.basixALPHA™ — Merit Medical Systems, Inc.basixCOMPAK™ — Merit Medical Systems, Inc.Encore 26 — BOSTON SCIENTIFIC CORPORATIONNamic — MEDLINE INDUSTRIES, INC.basixCOMPAK™ — Merit Medical Systems, Inc.GENOSS Inflator B40 — GENOSS CO., Ltd.GM-30 Accessory Kit — Nipro Vascular Innovations Americas, Inc.basixTOUCH™ — Merit Medical Systems, Inc.Angioway — Lepu Medical Technology (Beijing) Co.,Ltd.basixCOMPAK™ — Merit Medical Systems, Inc.BIG60ALPHA™ — Merit Medical Systems, Inc.Angioway — Lepu Medical Technology (Beijing) Co.,Ltd.Angioway — Lepu Medical Technology (Beijing) Co.,Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-04 | Merit Medical Systems, Inc. | Inflation device handle may detach from the syringe during procedure. |
| 2025-08-05 | Boston Scientific Corporation | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal inv |
| 2024-08-19 | Merit Medical Systems, Inc. | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which coul |
| 2024-08-19 | Merit Medical Systems, Inc. | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which coul |
| 2024-08-19 | Merit Medical Systems, Inc. | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which coul |
| 2024-08-19 | Merit Medical Systems, Inc. | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which coul |
| 2021-06-10 | Merit Medical Systems, Inc. | Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn. |
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